Leksell Stereotactic System, Injection/ Aspiration Needle Kit— 510(k) K152558

Clearance details

Applicant

Elekta Instrument AB

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2015-09-09

Decision date

2016-03-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Stockholm, SE

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
• K261932 — Leksell® Vantage Stereotactic System2026-08-05
• K253663 — Zeta Navigation System2026-05-01
• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K190887 — Leksell Vantage Stereotactic System2019-08-01
• K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2018-03-30
• K173791 — Leksell GammaPlan2018-02-09
• K171123 — Leksell Vantage Stereotactic System2017-09-15
• K160440 — Leksell Gamma Knife Icon2016-04-20

Death

52

Injury

1,083

Malfunction

17,300

Total

18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0227-2025 — Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.Class I·Ongoing·Elekta Instrument AB·20240925
• Z-1397-2024 — Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.Class I·Ongoing·Elekta Instrument AB·20240315
• Z-1309-2023 — Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.Class II·Ongoing·Elekta Instrument AB·20230301

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152558.